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Omeros Gets Orphan Status for PNH Therapy

[ Price : $8.95]

FDA grants Omeros an orphan drug designation for OMS906 and its use in treating paroxysmal nocturnal hemoglobinuria (PNH).

Regulatory Review Period for Accelerons Reblozyl

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Acceleron Pharmas Reblozyl ...

Siemens Healthineers Angiography System Cleared

[ Price : $8.95]

FDA clears a Siemens Healthineers 510(k) for the ARTIS icono ceiling, a ceiling-mounted angiography system designed for routine an...

FTC Endorsement Guides Require Attention: Lawyer

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Kleinfeld, Kaplan & Becker attorney Samantha Hong urges companies/marketers to evaluate and update their advertising and marketing...

FDA Corrects Notice on ANDA Withdrawals

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Federal Register notice: FDA corrects a notice that appeared in the 5/20 Federal Register announcing the approval withdrawals for ...

Califf Warns on User Fee Layoff Notices in September

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FDA commissioner Robert Califf warns that FDA employees affected by user fee funds could start getting layoff notices in early Sep...

Some UV Wands are Unsafe: FDA

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FDA warns consumers against using eight brands of ultraviolet wands for household disinfection due to the risk of unsafe radiation...

3 Lessons Learned from Fosamax Failure-to-Warn Case

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Attorney Daniel Feith describes three reasons why a recent New Jersey federal court decision helps manufacturers in failure-to-war...

Micro-Organospheres Show Cancer Proof of Concept: NCI

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The National Cancer Institute says researchers are expanding a study of micro-organospheres as a model to predict whether a cancer...

Acer Therapeutics NDA Resubmission Accepted

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FDA accepts for review an Acer Therapeutics NDA resubmission for ACER-001 (sodium phenylbutyrate) for oral suspension for treating...